Trial document




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  DRKS00006076

Trial Description

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Title

EEG-Neurofeedbacktraining in patients with ADHD at home - Group 3: Alternative training

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Trial Acronym

NF-Home-III

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URL of the Trial

http://www.meditec.hia.rwth-aachen.de/forschung/aktuelle-projekte/nf-home.html

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Brief Summary in Lay Language

EEG-based neurofeedback (NF) is an alternative option for the treatment of attention deficit hyperactivity disorder (ADHD). When using NF patients are supposed to gain regulatory control over their brain activity. However, often a significant number of training sessions is needed in order achieve symptom improvement (often > 30 sessions). In addition, improvement of training conditions is necessary, in particular such as training setups that allow training NF at home. NF-systems currently available cannot be used in home settings, have some technical disadvantages and need to be handled by trained staff. The goal of a large project is 1. to develop a new EEG-based NF-system that can be operated by lay people, and 2. the development of adapted and system-related therapy and session protocols for the use of NF at home. In the present sub-project as part of the overall project it is the aim to investigate the functionality of EEG-based NF for treatment of ADHD while using a new/alternative training protocol. It is the aim to recruit a small number of patients with ADHD (N = 6) for this study. Patients will receive 20 sessions of neurofeedback-training (NFT) while using established neurofeedback devices. NF will be provided by the parents for each subject with close consultation with a neurofeedback trainer. It is the aim of future studies to provide NFT in the home environment.

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Brief Summary in Scientific Language

EEG-based neurofeedback (NF) is an alternative option for the treatment of attention deficit hyperactivity disorder (ADHD). When using NF patients are supposed to gain regulatory control over their brain activity. However, often a significant number of training sessions is needed in order achieve symptom improvement (often > 30 sessions). In addition, improvement of training conditions is necessary, in particular such as training setups that allow training NF at home. NF-systems currently available cannot be used in home settings, have some technical disadvantages and need to be handled by trained staff. The goal of a
large project is 1. to develop a new EEG-based NF-system that can be operated by lay people, and 2. the development of adapted and system- related therapy and session protocols for the use of NF at home.

In the present sub-project as part of the overall project it is the aim to investigate functionality of EEG-based NF for treatment of ADHD while using a conventional training protocol. It is the aim to recruit a small number of patients with ADHD (N = 6) for this study. Patients will receive 20 sessions of neurofeedback-training (NFT) while using established neurofeedback devices. NF will be provided by the parents for each subject, with close consultation with a neurofeedback trainer (for a period of 4 days 2 training sessions per day, then 1 week off, then for 2 weeks 4 training sessions per week, then 4 weeks with 1 session per week). In order to measure symptom improvements pre- and post-training assessments comprising behavioural data and neuropsychological testing (objective computerized tasks, in particular for assessment of attentional performance) will be performed. In order to assess the stability of potential effects there will be a follow-up assessments 6 months after completion of the training sessions. It is the aim to compare the data of the present investigation with other data obtained within a study that comprised NFT delivered to young patients with ADHD by their parents whilst under supervision of a NF trainer (group 1). This particular group (group 1) received an intensive NFT with 5 sessions per week over a period of 2 weeks, followed by 2 sessions per week in a subsequent training period. Moreover, data from a further clinical group will be analysed retrospectively (outpatient NF program with NFT provide by trainers). The data will also be compared to a second group that received NFT by their parents in a standardized manner (group 2, study "EEG-Neurofeedbacktraining in patients with ADHD at home - Group 2: Conventional training", DRKS00004879).

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Organizational Data

  •   DRKS00006076
  •   2014/04/09
  •   [---]*
  •   yes
  •   Approved
  •   047/14, Ethik-Kommission an der Medizinischen Fakultät der RWTH Aachen
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   F90.0 -  Disturbance of activity and attention
  •   F90.1 -  Hyperkinetic conduct disorder
  •   F90.8 -  Other hyperkinetic disorders
  •   F90.9 -  Hyperkinetic disorder, unspecified
  •   F98.8 -  Other specified behavioural and emotional disorders with onset usually occurring in childhood and adolescence
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Interventions/Observational Groups

  •   20 sessions EEG-neurofeedback (for a period of 4 days 2 training sessions per day, then 1 week off, then for 2 weeks 4 training sessions per week, then 4 weeks with 1 session per week). Each session will have a duration of approximately 50 minutes. Training sessions will be conducted by the parents in close consultation with a neurofeedback trainer.
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Assesment of attentional performance (assessed with neuropsychological tests for attentional performance, subtests of the testbattery for attentional performance), assessed before and after completion of the neurofeedback training and after follow-up (approx. 6 months after completion of training). Used tasks: TAP (Testbatterie zur Aufmerksamkeitsprüfung), ANT (Amsterdam Neuropsychological Tasks).

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Secondary Outcome

Clinical symptoms (Child Behavior Checklist), assessed before and after completion of the neurofeedback training and after follow-up (approx. 6 months after completion of training)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2014/04/11
  •   6
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   8   Years
  •   17   Years
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Additional Inclusion Criteria

Diagnosis of ADHD, co-morbid conduct disorder will be tolerated.

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Exclusion Criteria

Epilepsy, treatment with neuroleptic medications at the time of the study, IQ below 80

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Addresses

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    • Klinik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters, Universitätsklinikum RWTH Aachen, LFG Translationale Hirnforschung in Psychiatrie und Neurologie
    • Mr.  Prof. Dr. med., Professor als Juniorprofessor  Florian Daniel  Zepf 
    • Neuenhofer Weg 21
    • 52074  Aachen
    • Germany
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    • Hasomed GmbH
    • Paul-Ecke-Straße 1
    • 39114  Magdeburg
    • Germany
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    •   0391-6230112
    •   0391-6230113
    •   [---]*
    •   [---]*
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    • Neuroconn GmbH
    • Grenzhammer 10
    • 98693  Ilmenau
    • Germany
    end of 1:1-Block address other
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    •   03677-689790
    •   03677-6897915
    •   [---]*
    •   [---]*
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    • Lehrstuhl für Medizinische Informationstechnik Helmholtz-Institut, RWTH Aachen
    • Pauwelsstr. 20
    • 52074  Aachen
    • Germany
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    •   0241-8023211
    •   0241-8082442
    •   [---]*
    •   [---]*
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    • Lehrstuhl für Medizintechnik, Helmholtz-Institut, RWTH Aachen
    • Pauwelsstr. 20
    • 52074  Aachen
    • Germany
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    •   024180-23870
    •   0241-8022870
    •   [---]*
    •   [---]*
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    • Klinik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters, Universitätsklinikum der RWTH Aachen
    • Mr.  Prof. Dr. med., Professor als Juniorprofessor  Florian Daniel  Zepf 
    • Neuenhofer Weg 21
    • 52074  Aachen
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
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    • Klinik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters, Universitätsklinikum der RWTH Aachen, LFG Translationale Hirnforschung in Psychiatrie und Neurologie
    • Ms.  Eva  Knospe 
    • Neuenhofer Weg 21
    • 52074  Aachen
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Wirtschaft und Technologie (BMWi)
    • Scharnhorststr. 34-37
    • 10115  Berlin
    • Germany
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    •   030-186150
    •   030-186157010
    •   [---]*
    •   [---]*
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Status

  •   Recruiting planned
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.